Oximetry probe with electronically selectable tissue depth analysis

ABSTRACT

An oximeter probe includes a probe unit or a base unit and a probe tip where the probe tip has a number of sources and detectors that can be accessed individually or in differing combinations for measuring tissue oxygen saturation at different tissue depth in tissue. A processor of the oximeter probe controls a multiplexer that is coupled to the detectors for selectively collecting measurement information from the detectors via the multiplexer. The oximeter probe is user programmable via one or more input devices on the oximeter probe for selecting the particular sources and detectors to collect measurement information from by the processor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the following U.S. patentapplications 62/325,403, 62/325,416, 62/325,413, filed Apr. 20, 2016,62/325,919, filed Apr. 21, 2016, 62/326,630, 62/326,644, 62/326,673,filed Apr. 22, 2016, and 62/363,562, filed Jul. 18, 2016. Theseapplications are incorporated by reference along with all otherreferences cited in these applications.

BACKGROUND OF THE INVENTION

The present invention relates to oximeter probes, such as compact,handheld oximeter probes, that include sources and detectors havingsource-to-detector spacing that can be user selected for probingdifferent tissue depth, that have sources that emit wavelengths of light(visible light, IR, or both) that can be user selected for probingdifferent tissue depth, or both.

Oximeters are medical devices used to measure tissue oxygen saturationof tissue in humans and living things for various purposes. For example,oximeters are used for medical and diagnostic purposes in hospitals andother medical facilities (e.g., operating rooms for surgery, recoveryroom for patient monitoring, or ambulance or other mobile monitoringfor, e.g., hypoxia); sports and athletic purposes at a sports arena(e.g., professional athlete monitoring); personal or at-home monitoringof individuals (e.g., local tissue health, regional tissue health,general health monitoring, or person training for a marathon); andveterinary purposes (e.g., animal monitoring).

In particular, assessing a patient's tissue oxygen saturation, at boththe regional and local level, is important as it is an indicator of thestate of the patient's local and regions tissue heath and can be anindicator of general health. Thus, oximeters are often used in clinicalsettings, such as during surgery and recovery, where it can be suspectedthat the patient's tissue oxygenation state is unstable. For example,during surgery, oximeters should be able to quickly deliver accuratetissue oxygen saturation measurements under a variety of non-idealconditions. While existing oximeters have been sufficient forpost-operative tissue monitoring where absolute accuracy is not criticaland trending data alone is sufficient, accuracy is, however, requiredduring surgery in which spot-checking can be used to determine whethertissue can remain viable or needs to be removed.

Pulse oximeters and tissue oximeters are two types of oximeters thatoperate on different principles. A pulse oximeter requires a pulse inorder to function. A pulse oximeter typically measures the absorbance oflight due to pulsing arterial blood. In contrast, a tissue oximeter doesnot require a pulse in order to function, and can be used to make tissueoxygen saturation measurements of a tissue flap that has beendisconnected from a blood supply.

Human tissue, as an example, includes a variety of light-absorbingmolecules. Such chromophores include oxygenated and deoxygenatedhemoglobins, melanin, water, lipid, and cytochrome. Oxygenated anddeoxygenated hemoglobins are the most dominant chromophores in tissuefor much of the visible and near-infrared spectral range. Lightabsorption differs significantly for oxygenated and deoxygenatedhemoglobins at certain wavelengths of light. Tissue oximeters canmeasure oxygen levels in human tissue by exploiting theselight-absorption differences.

Despite the success of existing oximeters, there is a continuing desireto improve oximeters by, for example, by providing oximeters that havesource-to-detector distances that are selectable for analyzing specifictissue depths, that emit wavelengths of light (visible light, IR, orboth) that can be user selected for probing different tissue depth, orboth. Therefore, there is a need for an improved tissue oximetry devicesand methods of making measurements using these devices.

BRIEF SUMMARY OF THE INVENTION

An oximeter probe having source-to-detector distances that are userselectable is provided for analyzing specific tissue depths of tissue,that emits wavelengths of light (visible light, IR, or both) that can beuser selected for probing different tissue depth, or both. The oximeterprobe has self-contained optics (sources and detectors), computerprocessing, a display, and a power-supply (battery) for self-containeduse.

The selectable tissue depth analysis allows a user to make oximetrymeasurements of specific tissue depths that can be varied while usingthe oximeter. For example, the oximeter can be set to make oximetermeasurements on a tissue flap that is being used to reconstruct tissue,such as breast tissue, and can be used to make oximeter measurements ofthe tissue below the tissue flap that that the flap is being attachedto. Thereby, a user can determine whether the tissue flap is healthy andcan be used for reconstruction, and whether the tissue to which thetissue flap is being connected is suitably healthy so that the tissueflap can survive reattachment to the patient.

In an implementation, a method includes providing a handheld oximeterhousing; providing a processor housed in the handheld oximeter housing;providing a memory, housed in the handheld oximeter housing,electronically coupled to the processor; providing a display, accessiblefrom an exterior of the handheld oximeter housing, electronicallycoupled to the processor; providing a battery, housed in the handheldoximeter housing; and allowing for the battery to supply power to theprocessor, the memory, and the display.

A probe tip is provided that includes a first source structure on a faceof the probe tip and a plurality of detector structures on the face ofthe first probe tip. The method includes allowing for the sourcestructure to emit first light having a first wavelength and second lighthaving a second wavelength into tissue to be measured where the firstwavelength is shorter than the second wavelength.

The method includes allowing for the detection of the first light by thedetector structures that are closer to the source structure than athreshold distance and determining, via the processor, first measurementinformation for first tissue of the tissue to be measured based on thefirst light detected by the detector structures that are closer to thesource structure than the threshold distance.

The method includes allowing for the detection of the second light bythe detector structures that are farther from the source structure thanthe threshold distance, and determining, via the processor, secondmeasurement information for second tissue of the tissue to be measuredbased on the second light detected by the detector structures that arefarther from the source structure than the threshold distance. The firsttissue is a first depth below a surface of the tissue to be measured,the second tissue is a second depth below the surface of the tissue tobe measured, and the first depth is less than the second depth.

In an implementation an oximeter probe includes a handheld oximeterhousing; a processor housed in the handheld oximeter housing; a memory,housed in the handheld oximeter housing, electronically coupled to theprocessor; a display, accessible from an exterior of the handheldoximeter housing, electronically coupled to the processor; and abattery, housed in the handheld oximeter housing where the battery iscoupled to and supplies power to the processor, the memory, and thedisplay.

The oximeter probe includes a probe tip housed at least partially in thehandheld oximeter housing. The probe tip includes a first sourcestructure on a face of the probe tip and a plurality of detectorstructures on the face of the first probe tip. The processor is adaptedfor: allowing for the source structure to emit first light having afirst wavelength and second light having a second wavelength into tissueto be measured. The first wavelength is shorter than the secondwavelength.

The processor is adapted for allowing for the detection of the firstlight by the detector structures that are closer to the source structurethan a threshold distance and determining first measurement informationfor first tissue of the tissue to be measured based on the first lightdetected by the detector structures that are closer to the sourcestructure than the threshold distance. The processor is adapted forallowing for the detection of the second light by the detectorstructures that are farther from the source structure than the thresholddistance and determining second measurement information for secondtissue of the tissue to be measured based on the second light detectedby the detector structures that are farther from the source structurethan the threshold distance. The first tissue is a first depth below asurface of the tissue to be measured, the second tissue is a seconddepth below the surface of the tissue to be measured, and the firstdepth is less than the second depth.

In an implementation, a method includes providing a handheld oximeterhousing; providing a processor housed in the handheld oximeter housing;providing a memory, housed in the handheld oximeter housing,electronically coupled to the processor, wherein the memory storessimulated reflectance curves; providing a display, accessible from anexterior of the handheld oximeter housing, electronically coupled to theprocessor; providing a battery, housed in the handheld oximeter housing;and allowing for the battery to supply power to the processor, thememory, and the display.

A probe tip is provided that is housed at least partially in thehandheld oximeter housing. The method includes providing a sourcestructure on a face of the probe tip and providing a plurality ofdetector structures on the face of the first probe tip.

The method includes allowing for the source structure to emit light intotissue to be measured; allowing for the detector structures to detectthe light subsequent to reflection from the tissue to be measured;allowing for the detector structures to generate reflectancemeasurements from the light detected by the detector structures.

The processor fits a first portion of the reflectance measurements tothe simulated reflectance curves, wherein the first portion of thereflectance data is generated by a first portion of detector structuresthat are closer than a threshold distance to the source structure.

The processor fits a second portion of the reflectance measurements tothe simulated reflectance curves. The second portion of the reflectancedata is generated by the first portion of the detector structures and afirst additional one of the detector structures. The first additionalone of the detector structures is farther than the threshold distancefrom the source structure.

The processor determines if the fit of the first portion of thereflectance measurements is a closer fit than the fit of the secondportion of the reflectance measurements. The processor then determinesfirst optical properties of the tissue using the first portion of thereflectance data and displays the first optical properties on thedisplay if the fit of the first portion of the reflectance data is acloser fit than the second portion of the reflectance measurements.

The processor fits a third portion of the reflectance measurements tothe simulated reflectance curves. The third portion of the reflectancedata is generated by the first portion of the detector structures, thefirst additional one of the detector structures, and a second additionalone of the detector structures. The second additional one of thedetector structures is farther than the first additional one of thedetector structures past the threshold distance from the sourcestructure.

The processor determines if the fit of second portion of the reflectancemeasurements is a closer fit than the fit of the third portion of thereflectance measurements. The processor determines second opticalproperties of the tissue using the second portion of the reflectancedata and displays the second optical properties on the display if thefit of the second portion of the reflectance data is a closer fit thanthe third portion of the reflectance measurements.

The processor determines third optical properties of the tissue usingthe third portion of the reflectance data and displays the third opticalproperties on the display if the fit of the third portion of thereflectance data is a closer fit than the second portion of thereflectance measurements.

In an implementation, a method includes providing a handheld oximeterhousing; providing a processor housed in the handheld oximeter housing;providing a memory, housed in the handheld oximeter housing,electronically coupled to the processor, providing a display, accessiblefrom an exterior of the handheld oximeter housing, electronicallycoupled to the processor; providing a battery, housed in the handheldoximeter housing, and allowing for the battery to supply power to theprocessor, the memory, and the display.

A first probe tip is provides that includes a first source structure anda first plurality of detector structures having a first arrangement. Themethod includes coupling the first probe tip to the handheld oximeterhousing. A second probe tip is provided that includes a second sourcestructure and a second plurality of detector structures having a secondarrangement. The first and second arrangements are differentarrangements. The method includes replacing the first probe tip with thesecond probe tip via coupling the second probe tip to the handheldoximeter housing such that the first arrangement is changed to thesecond arrangement.

Other objects, features, and advantages of the present invention willbecome apparent upon consideration of the following detailed descriptionand the accompanying drawings, in which like reference designationsrepresent like features throughout the figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows an oximeter probe and emitted radiation and detectedradiation for probing a number of tissue depths.

FIG. 1B shows an end view of the probe tip in an implementation.

FIG. 1C shows a block diagram of oximeter probe 101 in animplementation.

FIG. 2 shows a diagram of different tissue depths that can analyzed bythe oximeter probe.

FIG. 3 shows another diagram of different tissue depths of tissue probedby the oximeter probe using single detectors and combinations ofdetectors.

FIG. 4 is a block diagram of an oximeter probe in an implementation.

FIG. 5 shows the probe face of a probe tip that includes two sources S1and S2 and eight detectors D1-D8 in a circular configuration.

FIG. 6 shows an oximeter probe where the probe tip is detachable fromthe probe unit and where the probe unit can be replaced with a differentprobe tip.

FIG. 7 shows a tissue oximeter that includes a base unit and adetachable cable that includes a probe tip.

FIG. 8 shows a block diagram of two different probe tips having twodifferent source-to-detector spacings.

FIG. 9 shows a flow diagram of a method for weighting reflectance datagenerated by select ones of the detector structures.

FIG. 10 is an example graph of a number of Monte Carlo-simulatedreflectance curves.

FIG. 11A is a flow diagram of a method for determining the opticalproperties of tissue (e.g., real tissue) by tissue oximetry device wherethe tissue oximetry device uses reflectance data and simulatedreflectance curves to determine the optical properties.

FIG. 11B is a flow diagram of a method for finding the particularsimulated reflectance curve that best bits the reflectance data pointsin the fine grid according to one implementation.

FIG. 12 is a flow diagram of another method for determining the opticalproperties and tissue properties of real tissue by the tissue oximetrydevice.

FIG. 13 is a flow diagram of a method for weighting reflectance datagenerated by select detectors.

DETAILED DESCRIPTION OF THE INVENTION

The present invention generally relates to a wireless, handheld oximeterprobe for measuring tissue oxygen. The oximeter probe has a source and anumber of detectors that can be variously accessed for measuring tissueoxygen saturation from different tissue depths of tissue.

FIG. 1A shows a handheld oximeter probe 101. This oximeter probe is usedto make tissue oxygen saturation measurements of target tissue. In animplementation, the oximeter probe is a tissue oximeter, but in otherimplementation, the oximeter probe can be a pulse oximeter. Oximeterprobe 101 has two portions, a probe unit 105 and probe tip 110.

The handheld oximeter probe can be used in a variety of environments,such as surgical, sterile environment for spot measurements, doctorsoffices, at sporting events (e.g., personal and professional sportsuses), homes, retirement communities, hospice care, first responders(e.g., paramedics, emergency medical technicians, ambulance care, andfire fighters), pre-operative care, post-operative care, pediatric care,geriatric care, medical rehabilitation centers, veterinary uses, andother users. The use environments can also range from sterile, togenerally sanitary and cleanly environments (e.g., non-sterile recoveryrooms in a hospital, doctors offices, and other medical offices, homeuse, and other environments), and to environments that are typically notsanitary, such as mud, dirt, sand, and dusty environments, snow (e.g.,ski areas, ski patrol, and mountain climbing), rain, ice, and nearbodies of water (e.g., at swimming pools, beaches, and boats).

The oximeter probe has a display 115 (e.g., an LCD display) and a button120. When the button is depressed, light is emitted at the probe tipinto a target tissue to be measured, and reflected light from the targettissue is received at probe tip. The transmitted and received light areprocessed by the oximeter probe to determine a tissue oxygen saturationof the tissue. From the received light, the probe determines a measuredtissue oxygen saturation for the tissue. An indicator (e.g., a numericalvalue) for the measured tissue oxygen saturation is displayed on thedisplay.

The oximeter probe is shaped ergonomically to comfortably fit in auser's hand. During use, the probe is held in a user's hand between auser's thumb and fingers. The display faces toward the user's eyes whena face (not shown) of the probe tip is directed away from the user andfaces toward the target tissue to be measured.

In an implementation, light 145 is transmitted from a source in theprobe tip into the target tissue, and light 150 is reflected back to theprobe tip where the light is detected by one or more detectors. Thedetectors are located at increasing distances from the source. Lightdetected by the detectors is reflected back from depths within thetissue that increase with the increasing distances of the detectors fromthe source.

The probe unit can collect measurement information for the reflectedlight from one of the detectors or a combination of detectors fordetermining the tissue oxygen saturation at different tissue depths.

FIG. 1B shows an end view of probe tip 110 in an implementation. Probetip 110 is configured to contact tissue (e.g., a patient's skin) forwhich a tissue oximetry measurement is to be made. Probe tip 110includes first and second source structures 120 a and 120 b (generallysource structures 120) and includes first, second, third, fourth, fifth,sixth, seventh, and eighth detector structures 125 a-125 h (generallydetector structures 125). In alternative implementations, the oximeterprobe includes more or fewer source structures, includes more or fewerdetector structures, or both.

Each source structure 120 is adapted to emit light (such as infraredlight) and includes one or more light sources, such as four lightsources that generate the emitted light. Each light source can emit oneor more wavelengths of light. Each light source can include a lightemitting diode (LED), a laser diode, an organic light emitting diode(OLED), a quantum dot LED (QMLED), or other types of light sources.

Each source structure can include one or more optical fibers thatoptically link the light sources to a face 127 of the probe tip. In animplementation, each source structure includes four LEDs and includes asingle optical fiber that optically couples the four LEDs to the face ofthe probe tip. In alternative implementations, each source structureincludes more than one optical fiber (e.g., four optical fibers) thatoptically couples the LEDs to the face of the probe tip.

Each detector structure includes one or more detectors. In animplementation, each detector structure includes a single detectoradapted to detect light emitted from the source structures and reflectedfrom tissue. The detectors can be photodetectors, photoresistors, orother types of detectors. The detector structures are positioned withrespect to the source structures such that two or more (e.g., eight)unique source-to-detector distances are created.

In an implementation, the shortest source-to-detector distances areapproximately equal. For example, the shortest source-to-detectordistances are approximately equal between source structure 120 a anddetector structure 125 d (S1-D4) and between source structure 120 b anddetector structure 125 a (S2-D8) are approximately equal. The nextlonger source-to-detector distances (e.g., longer than each of S1-D4 andS2-D8) between source structure 120 a and detector structure 125 e(S1-D5) and between source structure 120 b and detector structure 125 a(S2-D1) are approximately equal. The next longer source-to-detectordistances (e.g., longer than each of S1-D5 and S2-D1) between sourcestructure 120 a and detector structure 125 c (S1-D3) and between sourcestructure 120 b and detector structure 125 g (S2-D7) are approximatelyequal. The next longer source-to-detector distances (e.g., longer thaneach of S1-D3 and S2-D7) between source structure 120 a and detectorstructure 125 f (S1-D6) and between source structure 120 b and detectorstructure 125 b (S2-D2) are approximately equal. The next longersource-to-detector distances (e.g., longer than each of S1-D6 and S2-D2)between source structure 120 a and detector structure 125 c (S1-D2) andbetween source structure 120 b and detector structure 125 f (S2-D6) areapproximately equal. The next longer source-to-detector distances (e.g.,longer than each of S1-D2 and S2-D6) between source structure 120 a anddetector structure 125 g (S1-D7) and between source structure 120 b anddetector structure 125 c (S2-D3) are approximately equal. The nextlonger source-to-detector distances (e.g., longer than each of S1-D7 andS2-D3) between source structure 120 a and detector structure 125 a(S1-D1) and between source structure 120 b and detector structure 125 e(S2-D5) are approximately equal. The next longer source-to-detectordistances (e.g., longest source-to-detector distance, longer than eachof S1-D1 and S2-D5) between source structure 120 a and detectorstructure 125 h (S1-D8) and between source structure 120 b and detectorstructure 125 d (S2-D4) are approximately equal. In otherimplementations, the source-to-detector distance can all be unique orhave fewer then eight distances that are approximately equal.

Table 1 below shows the eight unique source-to-detector distancesaccording to an implementation. The increase between nearestsource-to-detector distances is approximately 0.4 millimeters.

TABLE 1 Source-to-Detector Distances Source-to-Detector PairsMillimeters (S1-D4) 1.005 (S2-D8) 1.005 (S1-D5) 1.446 (S2-D1) 1.446(S1-D3) 1.883 (S2-D7) 1.883 (S1-D6) 2.317 (S2-D2) 2.317 (S1-S2) 2.749(S1-S2) 2.749 (S1-D7) 3.181 (S2-D3) 3.181 (S1-D1) 3.613 (S2-D5) 3.613(S1-D8) 4.004 (S2-D4) 4.004

In an implementation, detector structures 125 a and 125 e aresymmetrically positioned about a point that is on a straight lineconnecting sources 120 a and 120 b. Detector structures 125 b and 125 fare symmetrically positioned about the point. Detector structures 125 cand 125 g are symmetrically positioned about the point. Detectorstructures 125 d and 125 h are symmetrically positioned about the point.The point can be centered between source structures 120 a and 120 b onthe connecting line.

A plot of source-to-detector distance verses reflectance detected bydetector structures 125 can provide a reflectance curve where the datapoints are well spaced along the x-axis. These spacings of the distancesbetween source structures 120 a and 120 b, and detector structures 125reduces data redundancy and can lead to the generation of relativelyaccurate reflectance curves.

In an implementation, the source structures and detector structures canbe arranged at various positions on the probe surface to give thedistances desired (such as indicated above). For example, the twosources form a line, and there will be equal number of detectors aboveand below this line. And the position of a detector (above the line)will have point symmetry with another detector (below the line) about aselected point on the line of the two sources. As an example, theselected point may be the middle between the two sources, but notnecessarily. In other implements, the positioning can be arranged basedon a shape, such as a circle, an ellipse, an ovoid, randomly,triangular, rectangular, square, or other shape.

The following patent applications describe various oximeter devices andoximetry operation, and discussion in the following applications can becombined with aspects of the invention described in this application, inany combination. The following patent application are incorporated byreference along with all references cited in these application Ser. No.14/944,139, filed Nov. 17, 2015, Ser. No. 13/887,130 filed May 3, 2013,Ser. No. 15/163,565, filed May 24, 2016, Ser. No. 13/887,220, filed May3, 2013, Ser. No. 15/214,355, filed Jul. 19, 2016, Ser. No. 13/887,213,filed May 3, 2013, Ser. No. 14/977,578, filed Dec. 21, 2015, Ser. No.13/887,178, filed Jun. 7, 2013, Ser. No. 15/220,354, filed Jul. 26,2016, Ser. No. 13/965,156, filed Aug. 12, 2013, Ser. No. 15/359,570,filed Nov. 22, 2016, Ser. No. 13/887,152, filed May 3, 2013, Ser. No.29/561,749, filed Apr. 16, 2016, 61/642,389, 61/642,393, 61/642,395,61/642,399 filed May 3, 2012, and 61/682,146, filed Aug. 10, 2012.

FIG. 1C shows a block diagram of oximeter probe 101 in animplementation. Oximeter probe 101 includes display 115, a processor116, a memory 117, a speaker 118, one or more user-selection devices 119(e.g., one or more buttons, switches, touch input device associated withdisplay 115), a set of source structures 120, a set of detectorstructures 125, and a power source (e.g., a battery) 127. The foregoinglisted components may be linked together via a bus 128, which may be thesystem bus architecture of oximeter probe 101. Although this figureshows one bus that connects to each component, the busing isillustrative of any interconnection scheme serving to link thesecomponents or other components included in oximeter probe 101. Forexample, speaker 118 could be connected to a subsystem through a port orhave an internal direct connection to processor 116. Further, thecomponents described are housed in a mobile housing (see FIG. 1) ofoximeter probe 101 in an implementation.

Processor 116 may include a microprocessor, a microcontroller, amulti-core processor, or other processor type. Memory 117 may include avariety of memories, such as a volatile memory 117 a (e.g., a RAM), anonvolatile memory 117 b (e.g., a disk or FLASH). Differentimplementations of oximeter probe 101 may include any number of thelisted components, in any combination or configuration, and may alsoinclude other components not shown.

Power source 127 can be a battery, such as a disposable battery.Disposable batteries are discarded after their stored charge isexpended. Some disposable battery chemistry technologies includealkaline, zinc carbon, or silver oxide. The battery has sufficientstored charged to allow use of the handheld device for several hours.

In other implementations, the battery is rechargeable where the batterycan be recharged multiple times after the stored charge is expended.Some rechargeable battery chemistry technologies include nickel cadmium(NiCd), nickel metal hydride (NiMH), lithium ion (Li-ion), and zinc air.The battery can be recharged, for example, via an AC adapter with cordthat connects to the handheld unit. The circuitry in the handheld unitcan include a recharger circuit (not shown). Batteries with rechargeablebattery chemistry may be sometimes used as disposable batteries, wherethe batteries are not recharged but disposed of after use.

FIG. 2 shows a diagram of a probe tip that include one source S and fourof detectors D1, D2, D3, and D4 in an implementation. The detectors arelocated at increasing fixed distances (R1<R2<R3<R4) from the source.Detector D1, located at R1, is closest to the source and detects lightthat reflects within a first tissue layer that extends from the tissuesurface to a first tissue depth. Detector D2, located at R2, detectslight that reflects within a second tissue layer that extends from thefirst tissue depth to a second tissue depth. The second tissue depth isdeeper from the tissue surface than the first tissue depth. Detector D3,located at R3, detects light that reflects within a third tissue layerthat extends from the second tissue depth to a third tissue depth. Thethird tissue depth is deeper from the tissue surface than the secondtissue depth. Detector D4, located at R4, detects light that reflectswithin a fourth tissue layer that extends from the third tissue depth toa fourth tissue depth where the fourth tissue depth is deeper from thetissue surface than the third tissue depth. The oximeter probe uses themeasurement information collected from one or more of these detectors todetermine tissue oxygen saturation for one or more of the tissue depths.

While FIG. 2 shows that the probe tip includes a single detector foreach tissue layer, the probe tip can include a number of detectors foreach tissue layer, such as 2 detectors, 3 detectors, 4 detectors, 5detectors, 6 detectors, 7 detectors, 8 detectors, 9 detectors, 10detectors, or more detectors for each tissue layer. The probe tip canalso include more than one source, such as 2 sources, 3 sources, 4sources, 5 sources, 6 sources, 7 sources, 8 sources, 9 sources, 10sources, or more sources. The arrangement of sources and detectors canbe the arrangement of FIG. 1B where there are eight unique source todetector distances and each source to detector distance is duplicated atleast once.

FIG. 3 shows a number of different tissue depths than can be analyzed bythe oximeter probe for measurement information collected from a singledetector or combinations of detectors. For example, tissue oxygensaturation can be determined for the first, second, third, and fourthtissue layers by collecting measurement information respectively fromdetectors D1, D2, D3, and D4. Tissue oxygen saturation can also bedetermined for the fifth, sixth, seventh, and eighth tissue layers bycollecting measurements respectively from combinations of detectors:D1-D2; D2-D3; D3-D4; and D1-D4.

It can be appreciated that probe tips can include more than one sourceand greater or less then four detectors for determining tissue oxygensaturation for various tissue depths. It can also be appreciated thattwo more of the source-to-distance can be the same. For example,redundant source-to-detector distances can be used for calibrationpurposes or for self-checks of collected data.

In an implementation, the oximeter probe uses spatially resolvedspectroscopy to determine tissue oxygen saturation information for thedifferent tissue depths. Specifically, the oximeter probe uses: storedsource-to-detector distances for the sources and detectors, measurementinformation collected from one or more of the detectors for reflectedlight, and a spatially resolved spectroscopy method for calculating thetissue oxygen saturation information.

FIG. 4 is a block diagram of an oximeter probe in an implementation. Theprobe unit of the oximeter probe includes a processor and a multiplexerthat is electronically coupled to the processor. The probe tip includesthe source S and the detectors D1-D4. The probe unit also includes ananalog-to-digital converter (not shown) in the electronic path betweenthe detectors and the processor. The probe tip can include more sourcesand more or fewer detectors, such as the configuration of two sourcesand eight detectors shown in FIG. 1B and described above.

The processor controls the multiplexer to selectively collectmeasurement information for the reflected light that is detected by oneor more of the detectors. The processor uses the measurement informationto determine tissue oxygen saturation for one or more of the tissuedepths of the tissue.

In an implementation that includes more than one source, the sources canbe controlled by the processor such that one source is activated to emitlight, two sources are activated to emit light, three sources areactivated to emit light, or a greater number of sources are activated toemit light. The processor can allow data collection from one or more ofthe detectors for one or more of the sources that emit light such thatthe tissue can be probed at different depths to thereby determine oxygensaturation at the different tissue depths, such as described above withrespect to FIGS. 2-3.

FIG. 5 shows the probe face of a probe tip that includes two sources S1and S2 and eight detectors D1-D8 in an implementation. The sources anddetectors are arranged in a circular configuration. The probe face caninclude more or fewer sources and more or fewer detectors. The processorcontrols the multiplexer to transmit measurement information to theprocessor from one or more of the detectors for light emitted from oneor both of the sources. In alternative implementations, the sources anddetectors are arranged in other configurations, such as trapezoid,rectangle, square, triangular, linear, arbitrary, oval, elliptical, oneor more combinations of these shapes, or other shapes. The sources anddetectors can also be arranged in a nonplanar configurations, such as ona curved surface, where a curve of the curve surface can complement thatshape of a body part, such as the curve of a neck, head, knee, elbow,foot, or other body part to conform the sources and detectors to thecurved shapes.

FIG. 6 shows an oximeter probe 601 where the probe tip 605 is detachablefrom the probe unit 610. Probe tip 605 can be detached and replaced witha different probe tip 615 where the two probe tips have differentsource-to-detector spacings. For example, a first probe tip can have theconfiguration of sources and detectors of the probe tip shown in FIG. 1Band a second probe tip can have the configuration of sources anddetector of the probe tip shown in FIG. 5. The two different probe tipscan be used with the probe unit as a formed oximeter probe to determinetissue oxygen saturation for different tissue depths. In animplementation, the different probe tips have a different number ofsources, a different number of detectors, or both a different number ofsources and a different number of detectors.

FIG. 7 shows a tissue oximeter 701 that includes a base unit 705 and adetachable cable 712 that includes a probe tip 710 attached to an end ofthe cable. The probe tip includes one or more sources and one or moredetectors. The one or more sources and one or more detectors areseparated by a number of different source-to-detector distances. Thesource-to-detectors distances between sources emitting light anddetectors detecting light can be variously set for probing tissue atdifferent tissue depths below the surface of the tissue. The base unitcan be configured, for example by a user, such that one or more of thesources is configured to transmit light and one or more of the detectorsis configured to detect the light subsequent to reflection.

The base unit includes one or more user interfaces for receiving userinput for selecting one or more sources for emitting light and forreceiving user input for selecting one or more of detector for detectinglight. The one or more user interfaces of the base unit adapted toreceive user input can include buttons, a touch interface display,dials, switches, or other interfaces. The base unit can include one ormore communication ports adapted to receive information from a connectedcomputing device for selecting one or more sources for emitting lightand one or more detectors for detecting the light.

In an implementation, the cable and probe tip are detachable from thebase unit and can be replaced with a different cable and probe tip. Thetwo different probe tips of the two different cables have one or moredifferent source-to-detector distances between one or more sources andone or more detectors for probing different tissue depths.

FIG. 8 shows a block diagram of two different probe tips having twodifferent source-to-detector spacings. The probe tips include one sourceand four detectors. The probe tips can be switched so that differenttissue depths of tissue can be probed by the tissue oximeter. Forexample, the oximeter probe with the first probe tip can proberelatively shallow and deep tissue depths, whereas the oximeter probewith the second probe tip can probe relatively deep and intermediatetissue depths. It will be appreciated that the probe tips can includemore than one source and fewer or more detectors. In an implementation,each probe tip has an arrangement of one more sources and one or moredetectors in a circular arrangement.

In an implementation, a distance between at least one of the sources andat least one of the detectors is approximately 200 micrometers or less,such as 150 micrometers or less, 100 micrometers or less, 75 micrometersor less, or other distances. At least one of the sources that ispositioned 200 micrometers or less from one of the detectors emitsvisible light, infrared light, or both. Light emitted in the visiblespectrum can include wavelengths between blue light and red or lighthaving wavelengths of less than 580 nanometers, or both, such as greenlight, orange light, yellow light, or other colors of light havingwavelengths between the wavelengths of blue light and red light.

Light of relatively shorter wavelengths (e.g., wavelengths between bluelight and red light) may be transmitted from the probe tip for probingthe thin, top layers of tissue (e.g., 20 micrometers to about 150micrometers, or less), such as the epidermis. These relatively shorterwavelengths of light tend to penetrate less deeply into the dermis ornot penetrate the dermis so that measurement information from the dermisfrom these shorter wavelengths of light does not significantlycontribute to the measurement information from the epidermis. Therefore,chromophores in the epidermis, such as melanin, can be probed by theoximeter probe, and chromophores in the dermis may not contribute tomeasurements for melanin in the epidermis.

Light having relatively longer wavelengths can be selected for probingrelatively deeper into the tissue, such as deeper than about 20micrometers, deeper than about 50 micrometers, deeper than about 75micrometers, deeper than about 100 micrometers, deeper than about 125micrometers, or deeper than about 150 micrometers (e.g., deeper than thetissue depth of the epidermis, such as into the dermis, subcutaneousfat, or both).

In an implementation, measurement information for substantially all ofthe wavelengths of light (e.g., visible light, IR, or both) istransmitted from the sources into tissue and detected by the detectors.Reflectance data generated by the detectors for each of the wavelengthscan be analyzed, such as by fitting the reflectance data to simulatedreflectance curves to determine measurement values (e.g., absorptioncoefficients, reduced scattering coefficients, melanin concentration,oxygen saturation, blood volume, any combination of these measurements,or other measurements). Thereafter, the processor can use the measuredvalues, the reflectance data, or other information to determine measuredvalues for the various tissue layers at various tissue depths. Forexample, the processor can then determine one or more measurement values(e.g., absorption coefficients, reduced scattering coefficients, melaninconcentration, oxygen saturation, blood volume, any combination of thesemeasurements, or other measurements) for the epidermis that aresubstantially independent of measurement values for chromophores in thedermis. Fitting the reflectance data to the simulated reflectance curvesis describe further below.

The processor can also determine one or more measurement values (e.g.,oxygen saturation value) for the dermis that are substantiallyindependent of measurement values for chromophores in the epidermis.

In an implementations, select wavelengths (e.g., relatively shortwavelengths, such as between blue and red, or relatively longwavelengths, such as red, IR, or both) can be transmitted from thesources and detected by select ones of the detectors (e.g., selectdetectors 2-5 and 11-20 of 20 detectors, or select detectors 1 and 6-8of 20 detectors, or select detectors 9-13 of 20 detectors or some othernumber of detectors) to probe tissue, such as the epidermis or thedermis where measurement information for the epidermis is substantiallyindependent of measurement information for the dermis, and wheremeasurement information for the dermis is substantially independent ofmeasurement information for the epidermis, or finer gradations of thesetissue layers. For example, the relatively shorter wavelengths ofvisible light between blue and red can be transmitted from the sourcesand detected by the detectors that are relatively close to the sources(e.g., 100 micrometers or closer to the source) for probing theepidermis.

Relatively longer wavelengths of light (e.g., red, IR, or both) can betransmitted from the sources and detected by the detectors that arerelatively far from the sources (e.g., 100 micrometers or farther fromthe sources) for probing the dermis or deeper, such as buried skin flapused in flap replacement surgery for breast reconstruction, for example.The oximeter probe is adapted for receiving input for the selection ofcombinations of select wavelengths (e.g., short or long) and selectdetectors (e.g., close to the sources, such as closer then 100micrometers, or far from the sources, such as farther than 100micrometers) where the selected combination are used by the probe forprobing different tissue layers of tissue, such as the epidermis or thedermis. The oximeter probe is adapted to make these selections ofwavelengths and detectors based on select tissue depths that a user hasselected for probing or substantially automatically.

In an implementation, one or more sources can be adapted for emittingwavelengths of light in a first spectral range and not in a secondspectral range, or for emitting light in the second spectral range butnot the first spectral range where there first and second spectralranges may not overlap. The first spectral range may include light inthe visible range, such as at wavelengths between blue light and redlight. The second spectral range may include red light, IR, or both.

Data Weighting Detector Structures. Detector structures 125 that arepositioned at increasing distances from source structures 120 receivedecreasing amounts of reflectance from tissue. Therefore, thereflectance data generated by detector structures 125 having relativelyshort source-to-detector distances (e.g., S1-D4 and S2-D8 of FIG. 1B)tends to exhibit intrinsically higher signals compared to reflectancedata generated by detector structures having relatively longsource-to-detector distances (e.g., S1-D8 and S2-D4 of FIG. 1B). Fitalgorithms may therefore preferentially fit the simulated reflectancecurves to the reflectance data that is generated by detector structures125 having relatively short source-to-detectors distances (e.g.,source-to-detector distances less than or equal to the average distancebetween the source structures and the detector structures) more tightlythan reflectance data that is generated by detector structures havingrelatively long source-to-detector distances (e.g., source-to-detectordistances greater than the average distance). For relatively accuratedetermination of the optical properties from the reflectance data, thisdistance-proportional skew may be undesirable and may be corrected byweighting the reflectance data as described immediately below.

FIG. 9 shows a flow diagram of a method for weighting reflectance datagenerated by select detector structures 125. The flow diagram representsone example implementation. Steps may be added to, removed from, orcombined in the flow diagram without deviating from the scope of theimplementation.

At 1400, oximeter probe 101 emits light from one of the sourcestructures, such as source structure 120 a into tissue. After theemitted light reflects from the tissue, detector structures 125 detectthe light, step 1405, and generate reflectance data for the tissue, step1410. Steps 1400, 1405, and 1410 may be repeated for multiplewavelengths of light and for one or more other source structures, suchas source structure 120 b. At 1415, oximeter probe 101 fits a firstportion of the reflectance data to the simulated reflectance curves 315.The first portion of the reflectance data is generated by a firstportion of detector structures that are less than a threshold distancefrom the source structure. The threshold distance may be the averagedistances (e.g., approximate mid-range distance) between the sourcestructures and the detector structures. At 1420, reflectance data for asecond portion of the reflectance data is fitted to the simulatedreflectance curves. The second portion of reflectance data is generatedby the first portion of the detector structures and another detectorstructure that is at the next largest source-to-detector distance fromthe source compared to the threshold distance. For example, if the firstportion of detector structures includes detector structures 125 c, 125d, 125 e, and 125 f, then the detector structure that is at the nextlargest source-to-detector distance is detector structure 125 g (seeTable 1).

At 1425, the fit generated at step 1415 is compared to the fit generatedat step 1420 to determine whether the fit generated at step 1420 isbetter than the fit generated at 1415. As will be understood by those ofskill in the art, a “closeness” of a fit of data to a curve isquantifiable based on a variety of parameters, and the closeness of fitsare directly comparable to determine the data having a closer fit to acurve. As will be further understood, a closer fit is sometimes alsoreferred to as a better fit or a tighter fit. If the fit generated atstep 1420 is better than the fit generated at step 1415, then steps 1420and 1425 are repeated with reflectance data that is generated bydetector structures that include an additional detector structure(according to the example being considered, detector structure 125 c)that is positioned at a next increased source-to-detector distance fromthe source. Alternatively, if the fit generated at step 1420 is notbetter than the fit generated at step 1415, then the reflectance datafor detector structures 125 that are positioned at source-to-detectordistances that are greater than the threshold distance are not used inthe fit. Thereafter, oximeter probe 101 uses the fit generated at 1415or step 1420 (if better than the fit determined at step 1415) todetermine the optical properties and the oxygen saturation of thetissue, step 1430. Thereafter, oxygen saturation is reported by oximeterprobe 101, such as on display 115, step 1435.

According to an alternative implementation, if the fit generated at step1420 is not better than the fit generated at step 1415, then thereflectance data are weighted by a weighting factor for detectorstructures that have source-to-detector distances that are greater thanthe threshold distance so that this weighted reflectance data has adecreased influence on the fit. Reflectance data that is not used in afit may be considered as having a zero weight and may be associated withreflectance from tissue below the tissue layer of interest. Reflectancefrom tissue below the tissue layer of interest is said to exhibit acharacteristic kink in the reflectance curve that indicates thisparticular reflectance.

It is noted that curve-fitting algorithms that fit the reflectance datato the simulated reflectance curves may take into account the amount ofuncertainty of the reflectance data as well as the absolute location ofthe reflectance data. Uncertainty in the reflectance data corresponds tothe amount of noise from the generation of the reflectance data by oneof the detector structures, and the amount of noise can scale as thesquare root of the magnitude of the reflectance data.

According to a further implementation, oximeter probe 101 iterativelyweights the reflectance data based on the amount of noise associatedwith the measurements of the reflectance data. Specifically, thereflectance data generated by detector structures having relativelylarge source-to-detector distances generally have lower signal-to-noiseratio compared to the reflectance data generated by detector structurehaving relatively short source-to-detector distances. Weighting thereflectance data generated by detector structures having relativelylarge source-to-detector distances allows for this data to contribute tothe fit substantially equally to other reflectance data.

Stored Simulated Reflectance Curves. According to a specific embodiment,the memory stores a number of Monte Carlo-simulated reflectance curves315 (“simulated reflectance curves”), which may be generated by acomputer for subsequent storage in the memory. Each of the simulatedreflectance curves 315 represents a simulation of light (e.g., nearinfrared light) emitted from one or more simulated light sources intosimulated tissue and reflected from the simulated tissue into one ormore simulated detectors. Simulated reflectance curves 315 are for aspecific configuration of simulated light sources and simulateddetectors, such as the configuration of light sources 120 and detectors125 in tissue oximetry probe 127, or the like. Therefore, simulatedreflectance curves 315 model light emitted from, and collected by,tissue oximetry device 100. Further, each of the simulated reflectancecurves 315 represents a unique real tissue condition, such as specifictissue absorption and tissue scattering values that relate to particularconcentrations of tissue chromophores and densities of tissuescatterers. The number of simulated reflectance curves stored in memory117 may be relatively large and can represent nearly all, if not all,practical combinations of optical properties and tissue properties thatmay be present in real tissue that is analyzed for viability by tissueoximetry device 100. While memory 117 is described herein as storingMonte Carlo-simulated reflectance curves, memory 117 may store simulatedreflectance curves generated by methods other than Monte Carlo methods,such as using the diffusion approximation.

FIG. 10 is an example graph of a reflectance curve, which may be for aspecific configuration of light sources 120 and detectors 125, such asone of the configurations light sources and detectors of tissue oximetryprobe 127, or the like. The horizontal axis of the graph represents thedistances between light sources 120 and detectors 125 (i.e.,source-detector distances). If the distances between light sources 120and detectors 125 are appropriately chosen, and the simulatedreflectance curve is a simulations for light sources 120 and detectors125, then the lateral spacings between the data points in the simulatedreflectance curve will be relatively uniform. Such relatively uniformspacings can be seen in the simulated reflectance curve in FIG. 4. Thevertical axis of the graph represents the simulated reflectance of lightthat reflects from tissue and is detected by detectors 125. As shown bythe simulated reflectance curve, the reflectance that reaches detectors125 varies with the distance between light sources 120 and detectors125.

According to one implementation, memory 117 stores a select number ofpoints for each of the simulated reflectance curves 315 and might notstore the entirety of the simulated reflectance curves. The number ofpoints stored for each of simulated reflectance curves 315 may match thenumber of source-detector pairs. For example, if tissue oximetry probe115 includes two light sources 120 a and 120 c and includes eightdetectors 125 a-125 h, then tissue oximetry probe 100 includes sixteensource-detector pairs, and memory 117 may thus store sixteen select datapoints for each of the simulated reflectance curves, where stored datapoints are for the specific source-detectors distances (i.e., distancesbetween the light sources and the detectors).

Thus, the simulated reflectance curve database stored in memory 117might be sized 16×3×5850 where sixteen points are stored per curve forthree different wavelengths that may be generated and emitted by eachlight source 210 and wherein there are a total of 5850 curves spanningthe optical property ranges. Alternatively, the simulated reflectancecurve database stored in memory 117 might be sized 16×4×5850 whereinsixteen points are stored per curve for four different wavelengths thatmay be generated and emitted by each light source and wherein there area total of 5850 curves spanning the optical property ranges. The 5850curves originate, for example, from a matrix of 39 absorptioncoefficients μ_(s)′ values and 150 absorption coefficient μ_(a) values.The μ_(s)′ values might range from 5:5:24 centimeter⁻¹ (μ_(s)′ dependson the value for g). The μ_(a) values might range from 0.01:0.01:1.5. Itwill be understood the foregoing described ranges are example ranges andthe number source-detectors pairs, the number of wavelengths generatedby each light source, and the number of simulated reflectance curves maybe smaller or larger.

Tissue Analysis. FIG. 11A is a flow diagram of a method for determiningthe optical properties of tissue (e.g., real tissue) by tissue oximetrydevice 100 where the tissue oximetry device uses reflectance data andsimulated reflectance curves 315 to determine the optical properties.The optical properties may include the absorption coefficient μ_(a) andthe scattering coefficients μ_(s) of the tissue. A further method forconversion of the absorption coefficient μ_(a) and the scatteringcoefficients of the tissue μ_(s) to oxygen saturation values for tissueis described in further detail below. The flow diagram represents oneexample embodiment. Steps may be added to, removed from, or combined inthe flow diagram without deviating from the scope of the embodiment.

At 500, tissue oximetry device 100 emits light (e.g., near infraredlight) from one of the light sources 120, such as light source 120 ainto tissue. The tissue oximetry device is generally in contact with thetissue when the light is emitted from the light source. After theemitted light reflects from the tissue, detectors 125 detect a portionthis light, step 505, and generate reflectance data points for thetissue, step 510. Steps 500, 505, and 510 may be repeated for multiplewavelengths of light (e.g., red, near infrared light, or both) and forone or more other light sources, such as light source 120 c. Thereflectance data points for a single wavelength might include sixteenreflectance data points if, for example, tissue oximetry probe 115 hassixteen source-detectors distances. The reflectance data points aresometimes referred to as an N-vector of the reflectance data points.

At 515, the reflectance data points (e.g., raw reflectance data points)are corrected for gain of the source-detector pairs. During calibrationof the source-detector pairs, gain corrections are generated for thesource-detector pairs and are stored in memory 117. Generation of thegain corrections are described in further detail below.

At 520, processor 116 fits (e.g., via a sum of squares errorcalculation) the reflectance data points to the simulated reflectancecurves 315 to determine the particular reflectance data curve that bestfits (i.e., has the lowest fit error) the reflectance data points.According to one specific implementation, a relatively small set ofsimulated reflectance curves that are a “coarse” grid of the database ofthe simulated reflectance curves is selected and utilized for fittingstep 520. For example, given 39 scattering coefficient μ_(s)′ values and150 absorption coefficient μ_(a) values, a coarse grid of simulatedreflectance curves might be determined by processor 116 by taking every5th scattering coefficient μ_(s)′ value and every 8th absorptioncoefficients μ_(a) for a total of 40 simulated reflectance curves in thecoarse grid. It will be understood that the foregoing specific valuesare for an example embodiment and that coarse grids of other sizes mightbe utilized by processor 116. The result of fitting the reflectance datapoints to the coarse grid is a coordinate in the coarse grid(μ_(a),μ_(s)′)_(coarse) of the best fitting simulated reflectance curve.

At 525, the particular simulated reflectance curve from the coarse gridhaving the lowest fit error is utilized by processor 116 to define a“fine” grid of simulated reflectance curves where the simulatedreflectance curves in the fine grid are around the simulated reflectancecurve from the coarse grid having the lowest fit error.

That is, the fine grid is a defined size, with the lowest errorsimulated reflectance curve from the coarse grid defining the center ofthe fine grid. The fine grid may have the same number of simulatedreflectance curves as the coarse grid or it may have more or fewersimulated reflectance curves. The fine grid is substantially fine so asto provide a sufficient number of points to determine a peak surfacearray of nearby absorption coefficient μ_(a) values and scatteringcoefficient μ_(s)′ values, step 530, in the fine grid. Specifically, athreshold may be set by processor 116 utilizing the lowest error valuefrom the coarse grid plus a specified offset. The positions of thescattering coefficient μ_(s)′ and the absorption coefficient μ_(a) onthe fine grid that have errors below the threshold may all be identifiedfor use in determining the peak surface array for further determiningthe scattering coefficient μ_(s)′ and the absorption coefficient μ_(a)for the reflectance data. Specifically, an error fit is made for thepeak to determine the absorption coefficient μ_(a) and the scatteringcoefficient μ_(s)′ values at the peak. A weighted average (e.g., acentroid calculation) of the absorption coefficient μ_(a) and thescattering coefficient μ_(s)′ values at the peak may be utilized by thetissue oximetry device for the determination of the absorptioncoefficient μ_(a) and the scattering coefficient μ_(s)′ values for thereflectance data points for the tissue, step 540.

Weights for the absorption coefficient μ_(a) and the scatteringcoefficient μ_(s)′ values for the weighted average may be determined byprocessor 116 as the threshold minus the fine grid error. Because pointson the fine grid are selected with errors below the threshold, thisgives positive weights. The weighted calculation of the weighted average(e.g., centroid calculation) renders the predicted scatteringcoefficient μ_(s)′ and absorption coefficient μ_(a) (i.e.,(μ_(a),μ_(s)′)_(fine)) for the reflectance data points for the tissue.Other methods may be utilized by the tissue oximetry device, such asfitting with one or more of a variety of non-linear least squares todetermine the true minimum error peak for the scattering coefficient us.

According to one implementation, processor 116 calculates the log of thereflectance data points and the simulated reflectance curves, anddivides each log by the square root of the source-detector distances(e.g., in centimeters). These log values divided by the square root ofthe of the source-detector distances may be utilized by processor 116for the reflectance data points and the simulated reflectance curves inthe foregoing described steps (e.g., steps 515, 520, 525, and 530) toimprove the fit of the reflectance data points to the simulatedreflectance curves.

According to another implementation, the offset is set essentially tozero, which effectively gives an offset of the difference between thecoarse grid minimum and the fine grid minimum. The method describedabove with respect to FIG. 11A relies on minimum fit error from thecoarse grid, so the true minimum error on the fine grid is typicallylower. Ideally, the threshold is determined from the lowest error on thefine grid, which would typically require additional computation by theprocessor.

The following is a further detailed description for finding theparticular simulated reflectance curve that best fits the reflectancedata points in the fine grid according to one implementation. FIG. 11Bis a flow diagram of a method for finding the particular simulatedreflectance curve that best fits the reflectance data points in the finegrid according to one implementation. The flow diagram represents oneexample embodiment. Steps may be added to, removed from, or combined inthe flow diagram without deviating from the scope of the embodiment.

Subsequent to determining the particular simulated reflectance curve(μ_(a),μ_(s)′)_(coarse) from the coarse grid that best fits thereflectance data points at step 525, processor computes an error surfacein a region about (μ_(a),μ_(s)′)_(coarse) in the full simulatedreflectance curve database (i.e., 16×3×5850 (μ_(a),μ_(s)′) database) ofsimulated reflectance curves, step 550. The error surface is denoted as:err(μ_(a),μ_(s)′). Thereafter, processor 116 locates the minimum errorvalue in err(μ_(a),μ_(s)′), which is referred to as err_(min), step 555.Processor 116 then generates a peak surface array from err(μ_(a),μ_(s)′)that is denoted by pksurf (μ_(a),μ_(s)′)=k+err_(min)−err(μ_(a),μ_(s)′)if the peak surface is greater than zero, or pksurf(μ_(a),μ_(s)′)=k+err_(min)−err(μ_(a),μ_(s)′)=0 if the peak surface isless than or equal to zero, step 560. In the expression k is chosen froma peak at the minimum point of err(μ_(a),μ_(s)′) with a width above zeroof approximately ten elements. The center-of-mass (i.e., the centroidcalculation) of the peak in pksurf (μ_(a),μ_(s)′) uses the heights ofthe points as weights, step 565. The position of the center-of-mass isthe interpolated result for the absorption coefficient μ_(a) and thescattering coefficient μ_(s)′ for the reflectance data points for thetissue

The method described above with respect to FIGS. 11A and 11B fordetermining the absorption coefficient μ_(a) and the scatteringcoefficient μ_(s)′ for reflectance data points for tissue may berepeated for each of the wavelengths (e.g., 3 or 4 wavelengths)generated by each of light sources 120.

Oxygen Saturation Determination. According to a first implementation,processor 116 determines the oxygen saturation for tissue that is probedby tissue oximetry device 100 by utilizing the absorption coefficientsμ_(a) (e.g., 3 or 4 absorption coefficients μ_(a)) that are determined(as described above) for the 3 or 4 wavelengths of light that aregenerated by each light source 120. According to a first implementation,a look-up table of oxygen saturation values is generated for finding thebest fit of the absorption coefficients μ_(a) to the oxygen saturation.The look-up table may be generated by assuming a range of likely totalhemoglobin, melanin, and oxygen saturation values and calculating μ_(a)for each of these scenarios. Then, the absorption coefficient μ_(a)points are converted to a unit vector by dividing by a norm of the unitvector to reduce systematic error and only depend on relative shape ofcurve. Then the unit vector is compared to the look-up table to find thebest fit, which gives the oxygen saturation.

According to a second implementation, processor 116 determines theoxygen saturation for the tissue by calculating the net analyte signal(NAS) of deoxygenated hemoglobin and oxygenated hemoglobin. The NAS isdefined as the portion of the spectrum that is orthogonal to the otherspectral components in the system. For example, the NAS of deoxygenatedhemoglobin is the portion of the spectrum that is orthogonal tooxygenated hemoglobin spectrum and melanin spectrum. The concentrationsof deoxygenated and oxygenated hemoglobin can then be calculated byvector multiplying the respective NAS and dividing by a norm of the NASsquared. Oxygen saturation is then readily calculated as theconcentration of oxygenated hemoglobin divided by the sum of oxygenatedhemoglobin and deoxygenated hemoglobin. Anal. Chem. 58:1167-1172 (1986)by Lorber is incorporated by reference herein and provides a frameworkfor a further detailed understanding of the second implementation fordetermining the oxygen saturation for the tissue.

According to one embodiment of tissue oximetry device 100, thereflectance data is generated by detectors 125 at 30 Hertz, and oxygensaturation values are calculated at approximately 3 Hertz. A runningaverage of determined oxygen saturation values (e.g., at least threeoxygen saturation values) may be displayed on display 112, which mighthave an update rate of 1 Hertz.

Optical Properties. As described briefly above, each simulatedreflectance curve 315 that is stored in memory 117 represents uniqueoptical properties of tissue. More specifically, the unique shapes ofthe simulated reflectance curves, for a given wavelength, representunique values of the optical properties of tissue, namely the scatteringcoefficient (μ_(s)), the absorption coefficient (μ_(a)), the anisotropyof the tissue (g), and index of refraction of the tissue from which thetissue properties may be determined.

The reflectance detected by detectors 125 for relatively smallsource-to-detector distances is primarily dependent on the reducedscattering coefficient, μ_(s)′. The reduced scattering coefficient is a“lumped” property that incorporates the scattering coefficient μ_(s) andthe anisotropy g of the tissue where μ_(s)′=μ_(s)(1−g), and is used todescribe the diffusion of photons in a random walk of many steps of sizeof 1/μ_(s)′ where each step involves isotropic scattering. Such adescription is equivalent to a description of photon movement using manysmall steps 1/μ_(s) which each involve only a partial deflection angleif there are many scattering events before an absorption event, i.e.,μ_(a)<<μ_(s)′.

In contrast, the reflectance that is detected by detectors 125 forrelatively large source-detector distances is primarily dependent on theeffective absorption coefficient μ_(eff), which is defined as √{squareroot over (3μ_(a)(μ_(a)+μ_(s)′))}, which is a function of both μ_(a) andμ_(s)′.

Thus, by measuring reflectance at relatively small source-detectordistances (e.g., D1 between light source 120 a and detector 125 e and D9between light source 120 c and detector 125 a) and relatively largesource-detector distances (e.g., D5 between light source 120 a anddetector 125 a and D10 between light source 120 c and detector 125 e),both μ_(a) and μ_(s)′ can be independently determined from one another.The optical properties of the tissue can in turn provide sufficientinformation for the calculation of oxygenated hemoglobin anddeoxygenated hemoglobin concentrations and hence the oxygen saturationof the tissue.

Iterative Fit for Data Collection Optimization. FIG. 12 is a flowdiagram of another method for determining the optical properties oftissue by tissue oximetry device 100. The flow diagram represents oneexample embodiment. Steps may be added to, removed from, or combined inthe flow diagram without deviating from the scope of the embodiment.

At 600, tissue oximetry device 100 emits light (e.g., near infraredlight) from one of the light sources, such as light source 120 a intotissue. After the emitted light reflects from the tissue, detectors 125detect the light, step 605, and generate reflectance data for thetissue, step 610. Steps 600, 605, and 610 may be repeated for multiplewavelengths of light and for one or more other light sources, such aslight source 120 c. At 615, tissue oximetry device 100 fits thereflectance data to simulated reflectance curves 315 and determines thesimulated reflectance curve to which the reflectance data has the bestfit. Thereafter, tissue oximetry device 100 determines the opticalproperties (e.g., μ_(a), and μ_(s)′) for the tissue based on the opticalproperties of the simulated reflectance curve that best fits thereflectance data, step 620.

At 625 tissue oximetry device 100 determines the mean free path of thelight in the tissue from the optical properties (e.g.,mfp=1/(μ_(a)+μ_(s)′)) determined at step 620. Specifically, the meanfree path can be determined from the optical properties obtained from acumulative reflectance curve that includes the reflectance data for allof the source-detector pairs (e.g., pair 1: light source 120 a-detector125 e; pair 2: light source 120 a-detector 125 f; pair 3: light source120 a-detector 125 g; pair 4: light source 120 a-detector 125 h; pair 5:light source 120 a-detector 125 a; pair 6: light source 120 a-detector125 b; pair 7: light source 120 a-detector 125 c; pair 8: light source120 a-detector 125 d; . . . pair 9: light source 120 c-detector 125 e,pair 10: light source 120 b-detector 125 f . . . and others.).

At 630, tissue oximetry device 100 determines whether the mean free pathcalculated for a given region of the tissue is longer than two times theshortest source-to-detector distance (e.g., D1 between light source 120a and detector 125 e, and D9 between light source 120 c and detector 125a). If the mean free path is longer than two times the shortestsource-to-detector distance, then the collected reflectance data isre-fitted to the simulated reflectance curves (i.e., reanalyzed) withoututilizing the reflectance data collected from the detectors for thesource-to-detector pairs (e.g., pair 1: light source 120 a-detector 125e and pair 9 light source 120 c-detector 125 a) having the shortestsource-to-detector distance. For example, steps 615-630 are repeatedwithout use of the reflectance data from detector 125 e with lightsource 120 a acting as the source for detector 125 e, and without use ofthe reflectance data from detector 125 a with light source 120 c actingas the source for detector 125 a. The process of calculating the meanfree path and discarding the reflectance data for one or moresource-detector pairs may be repeated until no source-detector pairsthat contribute reflectance data to the fit have a source-to-detectordistance shorter than one half of the calculated mean free path.Thereafter, oxygen saturation is determined from the best fittingsimulated reflectance curve and reported by tissue oximetry device 110,such as on display 112, step 635.

Light that is emitted from one of the light sources 120 into tissue andthat travels less than half of the mean free path is substantiallynon-diffusely reflected. The re-emission distance for this light isstrongly dependent on the tissue phase function and the local tissuecomposition. Therefore, using the reflectance data for this light tendsto result in a less accurate determination of the optical properties andtissue properties as compared with the reflectance data for light thathas undergone multiple scattering events.

Data Weighting. Detectors 125 that are positioned at increasingdistances from light sources 120 receive decreasing amounts ofreflectance from tissue. Therefore, the reflectance data generated bydetectors 125 having relatively short source-to-detector distances(e.g., D1) tends to exhibit intrinsically lower noise compared toreflectance data generated by detectors having relatively longsource-to-detector distances (e.g., D5 and D10). Fit algorithms maytherefore preferentially fit the simulated reflectance curves to thereflectance data that is generated by detectors 125 having relativelyshort source-to-detectors distances (e.g., source-to-detector distancesless than or equal to the average distance between the light sources andthe detectors) more tightly than reflectance data that is generated bydetectors having relatively long source-to-detector distances (e.g.,source-to-detector distances greater than the average distance). Forrelatively accurate determination of the optical properties from thereflectance data, this distance-proportional skew may be undesirable andmay be corrected by weighting the reflectance data as describedimmediately below.

FIG. 13 is a flow diagram of a method for weighting reflectance datagenerated by select detectors 125. The flow diagram represents oneexample embodiment. Steps may be added to, removed from, or combined inthe flow diagram without deviating from the scope of the embodiment.

At 700, tissue oximetry device 100 emits light from one of the lightsources, such as light source 120 a into tissue. After the emitted lightreflects from the tissue, detectors 125 detect the light, step 705, andgenerate reflectance data for the tissue, step 710. Steps 700, 705, and710 may be repeated for multiple wavelengths of light and for one ormore other light sources, such as light source 120 c. At 715, tissueoximetry device 100 fits a first portion of the reflectance data to thesimulated reflectance curves. The first portion of the reflectance datais generated by a first portion of detectors that are less than athreshold distance from the light source. The threshold distance may bethe average distances (e.g., approximate mid-range distance) between thelight sources and the detectors. At 720, reflectance data for a secondportion of the reflectance data is fitted to the simulated reflectancecurves. The second portion of reflectance data is generated by the firstportion of the detectors and another detector that is at the nextlargest source-to-detector distance from the source compared to thethreshold distance. For example, if the first portion of detectorsincludes detectors 125 c, 125 d, 125 e, and 125 f, then the detectorthat is at the next largest source-to-detector distance is detector 125g (e.g., closer to light source 120 a than detector 125 c, see FIG. 1B.

At 725, the fit generated at step 715 is compared to the fit generatedat step 720 to determine whether the fit generated at step 720 is betterthan the fit generated at 715. As will be understood by those of skillin the art, a “closeness” of a fit of data to a curve is quantifiablebased on a variety of parameters, and the closeness of fits are directlycomparable to determine the data having a closer fit (closer fit) to acurve. As will be further understood, a closer fit is sometimes alsoreferred to as a better fit or a tighter fit. If the fit generated atstep 720 is better than the fit generated at step 715, then steps 720and 725 are repeated with reflectance data that is generated bydetectors that include an additional detector (according to the examplebeing considered, detector 125 c) that is positioned at a next increasedsource-to-detector distance from the source. Alternatively, if the fitgenerated at step 720 is not better than the fit generated at step 715,then the reflectance data for detectors 125 that are positioned atsource-to-detector distances that are greater than the thresholddistance are not used in the fit. Thereafter, tissue oximetry device 100uses the fit generated at 715 or step 720 (if better than the fitdetermined at step 715) to determine the optical properties and theoxygen saturation of the tissue, step 730. Thereafter, oxygen saturationis reported by tissue oximetry device 110, such as on display 112, step735.

According to an alternative embodiment, if the fit generated at step 720is not better than the fit generated at step 715, then the reflectancedata are weighted by a weighting factor for detectors that havesource-to-detector distances that are greater than the thresholddistance so that this weighted reflectance data has a decreasedinfluence on the fit. Reflectance data that is not used in a fit may beconsidered as having a zero weight and may be associated withreflectance from tissue below the tissue layer of interest. Reflectancefrom tissue below the tissue layer of interest is said to exhibit acharacteristic kink in the reflectance curve that indicates thisparticular reflectance.

It is noted that curve-fitting algorithms that fit the reflectance datato the simulated reflectance curves may take into account the amount ofuncertainty of the reflectance data as well as the absolute location ofthe reflectance data. Uncertainty in the reflectance data corresponds tothe amount of noise from the generation of the reflectance data by oneof the detectors, and the amount of noise can scale as the square rootof the magnitude of the reflectance data.

According to a further embodiment, tissue oximetry device 100iteratively weights the reflectance data based on the amount of noiseassociated with the measurements of the reflectance data. Specifically,the reflectance data generated by detectors having relatively largesource-to-detector distances generally have greater a greatersignal-to-noise ratio compared to the reflectance data generated bydetector having relatively short source-to-detector distances. Weightingthe reflectance data generated by detectors having relatively largesource-to-detector distances allows for this data to contribute to thefit substantially equally to other reflectance data.

This description of the invention has been presented for the purposes ofillustration and description. It is not intended to be exhaustive or tolimit the invention to the precise form described, and manymodifications and variations are possible in light of the teachingabove. The embodiments were chosen and described in order to bestexplain the principles of the invention and its practical applications.This description will enable others skilled in the art to best utilizeand practice the invention in various embodiments and with variousmodifications as are suited to a particular use. Elements of the variousdescribed implementations can be combined in any combination. The scopeof the invention is defined by the following claims.

The invention claimed is:
 1. A method comprising: providing a handheldoximeter housing; providing a processor housed in the handheld oximeterhousing; providing a memory, housed in the handheld oximeter housing,electronically coupled to the processor; providing a display, accessiblefrom an exterior of the handheld oximeter housing, electronicallycoupled to the processor; providing a battery, housed in the handheldoximeter housing; providing for the battery to supply power to theprocessor, the memory, and the display; providing a probe tip housed atleast partially in the handheld oximeter housing; providing a firstsource structure on a face of the probe tip; providing a plurality ofdetector structures on the face of the probe tip; providing for thefirst source structure to emit first light having a first wavelength andsecond light having a second wavelength into tissue to be measured,wherein the first wavelength is shorter than the second wavelength;providing for a detection of the first light by the detector structuresthat are closer to the source structure than a threshold distance;fitting, by the processor, first detector responses, that are generatedby the detector structures that are closer to the source structure thanthe threshold distance based on the detected first light, to a pluralityof simulated reflectance curves stored in the memory; determining, bythe processor, first measurement information for first tissue of thetissue to be measured, based on one or more best fitting ones of thesimulated reflectance curve to the first detector responses; providingfor the detection of the second light by the detector structures thatare farther from the source structure than the threshold distance; andfitting, by the processor, second detector responses, that are generatedby the detector structures that are farther from the source structurethan the threshold distance based on the detected second light, to theplurality of simulated reflectance curves stored in the memory;determining, by the processor, second measurement information, based onone or more best fitting ones of the simulated reflectance curve to thesecond detector responses; determining, via the processor, secondmeasurement information for second tissue of the tissue to be measuredbased on the second light detected by the detector structures that arefarther from the source structure than the threshold distance; based onthe first measurement information, calculating and displaying on thedisplay a first oxygen saturation measurement for a first tissue regionbelow a surface of the tissue at a first depth; based on the secondmeasurement information, calculating and displaying on the display asecond oxygen saturation measurement for a second tissue region belowthe surface of the tissue at a second depth; and based on the firstmeasurement information and the second measurement information,calculating and displaying on the display a third oxygen saturationmeasurement for a third tissue region below the surface of the tissue ata combination of the first and second depths, wherein the first tissueis a first depth below the surface of the tissue to be measured, thesecond tissue is a second depth below the surface of the tissue to bemeasured, and the first depth is less than the second depth.
 2. Themethod of claim 1 wherein the first measurement information is firstoximetry information and the second information is second oximetryinformation.
 3. The method of claim 1 comprising: providing amultiplexer, housed in the handheld oximeter housing, coupled to theprocessor; and providing the multiplexer to route signals to theprocessor from the detector structures that are closer to the sourcestructure than the threshold distance.
 4. The method of claim 3comprising providing the multiplexer to not route signals to theprocessor from the detector structures that are farther from the sourcestructure than the threshold distance.
 5. The method of claim 3 whereinthe detector structures have an average distance from the first sourcestructure and the threshold distance is the average distance.
 6. Themethod of claim 1 providing for a user selection of a tissue depth ofthe tissue to be measured for determining the first, second, or thirdoxygen saturation.
 7. The method of claim 1 wherein the determining, bythe processor, second measurement information, based on one or more bestfitting ones of the simulated reflectance curve to the second detectorresponses, comprises performing a sum of squares error calculation todetermine a specific simulated reflectance curve that has the lowest fiterror.
 8. The method of claim 1 comprising providing a multiplexercoupled between the processor and the detector structures.
 9. The methodof claim 1 comprising providing a probe cover for the handheld oximeterhousing comprising: a first portion of the probe cover, wherein thefirst portion comprises a first open end and a first closed end,opposite to the first open end, and the first closed end comprises adisplay panel; a second portion of the probe cover, wherein the secondportion comprises a second open end and a second closed end, opposite tothe second open end, the second closed end comprises an optical sensorpanel, and coupling of the first open end to the second open end forms asealed probe cover enclosure for the oximeter device, the optical sensorpanel is transparent and comprises a thickness of less than about 250microns, when in the sealed probe cover enclosure, a display of theoximeter device is visible through the display panel of the probe cover,light emitted by a probe tip of the oximeter device is transmittedthrough the optical sensor panel of the probe cover, and light receivedat the oximeter device is transmitted through the optical sensor panelof the probe cover, the sealed probe cover enclosure preventscontaminants from outside of the enclosure from contacting the oximeterdevice contained within an interior of the enclosure, and the secondportion of the probe cover comprises a barrier at the second closed end,the barrier is coupled to the optical sensor panel, and the barrierprevents contaminants on a tissue being measured from contacting theoximeter contained within the interior of the enclosure.
 10. The methodof claim 9 wherein the optical sensor panel passes light in a wavelengthrange from about 650 nanometers to about 900 nanometers withoutattenuation that would affect an oximeter measurement.
 11. The method ofclaim 9 wherein the optical sensor panel comprises a thickness of lessthan about 150 microns.
 12. The method of claim 9 wherein the opticalsensor panel comprises a thickness of less than about 100 microns. 13.The method of claim 9 wherein the optical sensor panel comprises athickness of less than about 50 microns.
 14. The method of claim 9wherein the thickness of the optical sensor panel comprises a uniformthickness.
 15. The method of claim 9 wherein a first surface of theoptical sensor panel conforms to a surface of a sensor of the probe tipof the oximeter device, and the first surface is configured to be flushagainst the sensor of the probe tip without any gaps.
 16. The method ofclaim 9 wherein the probe cover comprises polycarbonate.
 17. The methodof claim 9 wherein the probe cover comprises a rigid polymer.
 18. Themethod of claim 9 wherein the optical sensor panel comprisespolycarbonate.
 19. The method of claim 9 wherein the second portion ofthe probe cover comprises rigid polymer, and the optical sensor panelcomprises a flexible polymer, in relation to the rigid polymer.
 20. Themethod of claim 9 wherein the second portion of the probe covercomprises flexible polymer, and the optical sensor panel comprises arigid polymer, in relation to the flexible polymer.
 21. A devicecomprising: a handheld oximeter housing; a processor housed in thehandheld oximeter housing; a memory, housed in the handheld oximeterhousing, electronically coupled to the processor and storing a pluralityof simulated reflectance curves; a display, accessible from an exteriorof the handheld oximeter housing, electronically coupled to theprocessor; a battery, housed in the handheld oximeter housing, whereinthe battery is coupled to and supplies power to the processor, thememory, and the display; a probe tip housed at least partially in thehandheld oximeter housing; a first source structure on a face of theprobe tip; and a plurality of detector structures on the face of theprobe tip; wherein the processor is adapted for: providing for thedetection of a first light by the detector structures that are closer tothe first source structure than a threshold distance; fitting, by theprocessor, first detector responses, that are generated by the detectorstructures that are closer to the source structure than the thresholddistance based on the detected first light, to the plurality ofsimulated reflectance curves stored in the memory; determining, by theprocessor, first measurement information, based on one or more bestfitting ones of the simulated reflectance curve to the first detectorresponses; providing for the detection of a second light by the detectorstructures that are farther from the source structure than the thresholddistance; fitting, by the processor, second detector responses, that aregenerated by the detector structures that are farther from the sourcestructure than the threshold distance based on the detected secondlight, to the plurality of simulated reflectance curves stored in thememory; determining, by the processor, second measurement information,based on one or more best fitting ones of the simulated reflectancecurve to the second detector responses; determining, via the processor,second measurement information for a tissue to be measured based on thesecond light detected by the detector structures that are farther fromthe source structure than the threshold distance; based on the firstmeasurement information, calculating and displaying on the display afirst oxygen saturation measurement for a first tissue region below asurface of a tissue at a first depth; based on the second measurementinformation, calculating and displaying on the display a second oxygensaturation measurement for a second tissue region below the surface ofthe tissue at a second depth; and based on the first measurementinformation and the second measurement information, calculating anddisplaying on the display a third oxygen saturation measurement for athird tissue region below the surface of the tissue at a combination ofthe first and second depths, wherein the first tissue region is a firstdepth below a surface of the tissue to be measured, the second tissueregion is a second depth below the surface of the tissue to be measured,and the first depth is less than the second depth.
 22. The device ofclaim 21 wherein the first measurement information is first oximetryinformation and the second information is second oximetry information.23. The device of claim 21 comprising a multiplexer, housed in thehandheld oximeter housing, coupled to the processor, wherein theprocessor is adapted for providing the multiplexer to route signals tothe processor from the detector structures that are closer to the sourcestructure than the threshold distance.
 24. The device of claim 23wherein the processor is adapted for providing the multiplexer to notroute signals to the processor from the detector structures that arefarther the source structure than the threshold distance.
 25. The deviceof claim 23 wherein the detector structures have an average distancefrom the first source structure and the threshold distance is theaverage distance.
 26. The device of claim 21 comprising providing for auser selection of a tissue depth of the tissue to be measured fordetermining the first, second, or third oxygen saturation.
 27. Thedevice of claim 26 comprising providing a multiplexer coupled betweenthe processor and the detector structures.